Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
FDA product code LJM · 109 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.5100
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1982-10-08 – 2018-11-27
LJM
2018-11-27
LJM
2016-03-11
ImmuLisa Enhanced Centromere Antibody ELISA
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LJM
2013-07-15
ANA SCREEN ELISA (IGG)
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LJM
2009-03-13
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
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LJM
2005-06-28
VARELISA RECOMBI CTD SCREEN, MODEL 13096
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LJM
2005-04-26
VARELISA RECOMBI ANA PROFILE, MODEL 18496
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LJM
2004-10-26
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
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LJM
2004-06-23
AESKULISA ANA HEP-2
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LJM
2004-05-14
VARELISA HISTONE ANTIBODIES, MODEL 16496
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LJM
2004-03-11
EL-ANA PROFILES: ANTI-CHROMATIN
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LJM
2004-03-04
MESACUP-2 TEST CENP-B
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LJM
2003-05-02
ANA DETECT
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LJM
2003-02-06
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
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LJM
2002-07-05
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
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LJM
2001-02-15
ANA EIA DIAGNOSTIC TEST KIT
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LJM
2001-01-22
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
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LJM
2000-09-12
EL-ANA PROFILES-2K1
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LJM
2000-05-22
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
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LJM
2000-05-22
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
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LJM
2000-04-07
MDI SCL-70 TEST
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LJM
2000-01-18
RHIGENE ANA ELISA TEST SYSTEM
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LJM
2000-01-10
MDI SS-A TEST
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LJM
2000-01-10
MDI SM/RNP TEST
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LJM
1999-11-12
VARELISA RECOMBI ANA PROFILE
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LJM
1999-11-12
VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96
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LJM
1999-07-23
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
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LJM
1999-01-28
AUTOSTAT II ANA SCREEN ELISA
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LJM
1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.
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LJM
1998-05-12
SERAQUEST ANTI-SSA
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LJM
1998-05-12
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
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LJM
1997-03-06
ELIAS ANA-HEP-2
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LJM
1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
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LJM
1996-11-18
ORGENTEC ANTI-SM ELISA
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LJM
1996-11-18
ORGENTEC ANTI-RNP/SM ELISA
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LJM
1996-11-15
ORGENTEC ANTI-SCL 70 ELISA
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LJM
1996-11-15
ORGENTEC ANTI-SS-A(RO) ELISA
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LJM
1996-11-15
ORGENTEC ANTI-JO-1 ELISA
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LJM
1996-11-15
ORGENTEC ABTI-SS-BB(LA) ELISA
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LJM
1996-09-30
VARELISA ANA (4) PROFILE
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LJM
1996-04-18
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
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LJM
1996-04-18
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
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LJM
1996-04-18
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
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LJM
1996-04-18
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
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LJM
1996-03-06
THERATEST KIT (MODIFICATION)
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LJM
1996-02-29
QUANTA LITE SSDNA
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LJM
1995-12-15
IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM
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LJM
1995-11-14
THERATEST LAB, INC., EL-ANASCR KIT
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LJM
1995-09-26
THERATEST EL-ANA PROFILES TEST SYSTEM
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LJM
1995-07-18
ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
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LJM
1995-07-17
ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT
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LJM
1995-05-15
MARDX MITOCHONDRIA EIA TEST SYSTEM
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LJM
1995-05-15
MARDX ENA EIA TEST SYSTEM
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LJM
1995-04-17
VARELISA HISTONE ANTIBODIES
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LJM
1995-04-17
VARELISA ANA PROFILE
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LJM
1995-04-17
VARELISA ANA-4 SCREEN
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LJM
1995-01-20
ANTI-HISTONE ANIBODY TEST
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LJM
1994-12-22
VARELISA JO-1 ANTIBODIES
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LJM
1994-12-22
VARELISA SCL-70 ANTIBODIES
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LJM
1994-12-22
VARELISA CENTROMERE ANTIBODIES
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LJM
1994-12-22
VARELISA SM ANTIBODIES
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LJM
1994-12-22
VARELISA RO (SS-A) ANTIBODIES
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LJM
1994-12-22
VARELISA LA (SS-B) ANTIBODIES
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LJM
1994-12-22
VARELISA RNP-SM ANTIBODIES
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LJM
1994-06-30
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
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LJM
1994-06-10
ENA PROFILE-6 ELISA TEST SYSTEM
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LJM
1994-06-10
ENA SCREEN ELISA TEST SYSTEM
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LJM
1994-06-10
AUTOZYME SCREEN
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LJM
1994-05-02
HISTONE EIA TEST KIT
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LJM
1994-05-02
RO EIA TEST KIT
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LJM
1994-05-02
RNP EIA TEST KIT
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LJM
1994-05-02
SM EIA TEST KIT
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LJM
1994-03-25
ELIAS ANA TOTAL
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LJM
1994-03-25
SYNELISA ANA TOTAL
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LJM
1993-12-15
AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM
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LJM
1993-12-03
SYNELISA ANA PROFILE
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LJM
1993-08-10
ANA PROFILE I
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LJM
1993-06-11
SYNELISA RO ABS / LA ABS
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LJM
1992-11-02
ACCUTEX SLE LATEX TEST
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LJM
1992-11-02
KALESTAD ANA MICROPLATE EIA
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LJM
1992-07-14
DIASTAT ANTI-HISTONE KIT
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LJM
1992-03-17
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
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LJM
1992-01-15
ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT
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LJM
1991-01-25
UBI MAGIWEL(TM) ANA QUANTITATIVE
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LJM
1990-12-07
DIASTAT ENA PROFILE
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LJM
1990-09-06
ANTI-SCI-70 MICROASSAY
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LJM
1990-01-24
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
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LJM
1989-12-05
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
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LJM
1989-10-27
RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES
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LJM
1989-10-24
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
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LJM
1989-08-24
ANTI-SM MICROASSAY
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LJM
1989-05-09
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
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LJM
1988-03-11
LA ANTIBODY TEST KIT
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LJM
1988-02-10
LIPOGEN ANA TEST KIT
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LJM
1987-10-20
ANTINUCLEAR ANTIBODY TEST
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LJM
1987-03-24
DS-DNA EIA DIAGNOSTIC KIT
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LJM
1987-03-17
RNP EIA DIAGNOSTIC KIT
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LJM
1987-03-17
DNP EIA DIAGNOSTIC KIT
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LJM
1987-03-17
SM EIA DIAGNOSTIC KIT
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LJM
1987-03-17
SS-DNA EIA DIAGNOSTIC KIT
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LJM
1986-10-24
ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT
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